PAtients With Symptomatic Peripheral Artery Disease on Rivaroxaban-acetylsalicylic Acid Combination Therapy (PRO-PAS)

NCT06239415 | Recruiting

• 1 other identifier: 2605CE
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

The observational, prospective, multicenter study enrolls patients experiencing symptomatic peripheral atherosclerotic disease in the lower limb, with or without chronic ischemic heart disease, and who have an indication for treatment with rivaroxaban 2.5 mg twice daily and ASA 100 mg. The study's objective is to assess adherence to the prescribed treatment after 3 months and 12 months from enrollment, as well as to monitor any adverse events that may occur during this period.

Conditions

Peripheral Atherosclerotic Disease

Outcome Measures

Primary Outcomes (2)

• Adherence to the prescribed medical treatment

  Adherence to the prescribed medical treatment measured by the Morisky Medication. Adherence Scale. The scores range from 0 to 8, with scores of 8 reflecting high adherence, 7 or 6 reflecting medium adherence, and \<6 reflecting low adherence.

  3 months

• Adherence to the prescribed medical treatment

  Adherence to the prescribed medical treatment measured by the Morisky Medication Adherence Scale. The scores range from 0 to 8, with scores of 8 reflecting high adherence, 7 or 6 reflecting medium adherence, and \<6 reflecting low adherence.

  12 months

Secondary Outcomes (2)

• Adverse event

  3 months

• Adverse event

  12 months

Interventions

observation OTHER

Observation for 1 year of patients suffering from symptomatic peripheral atherosclerotic disease of the lower limb, with or without chronic ischemic heart disease, and indication for treatment with rivaroxaban 2.5 mg bid and acetylsalicylic acid 100 mg.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients suffering from symptomatic peripheral atherosclerotic disease of the lower limb, with or without chronic ischemic heart disease, and indication for treatment with rivaroxaban 2.5 mg bid and acetylsalicylic acid 100 mg

You may qualify if:

• Patients with symptomatic peripheral atherosclerotic disease of the lower extremity
• Ability to provide written informed consent.

You may not qualify if:

• Need for dual antiplatelet therapy, or therapy with antiplatelet agents other than aspirin or oral anticoagulant therapy (full dose)
• Ischemic stroke within the previous 1 month or any history of hemorrhagic or lacunar stroke
• Dialysis or estimated glomerular filtration rate \<15 mL/min
• Known non-cardiovascular disease associated with poor prognosis (e.g. metastatic cancer)
• History of known hypersensitivity to rivaroxaban, aspirin or excipients
• Presence of contraindications to rivaroxaban and/or aspirin (as indicated in the technical data sheet)
• Systemic treatment with strong inhibitors of CYP 3A4 or p-glycoprotein (e.g. systemic antifungals, such as ketoconazole and human immunodeficiency virus \[HIV\] protease inhibitors, such as ritonavir) or strong inducers of CYP 3A4, e.g. Rifampicin, Rifabutin, Phenobarbital, Phenytoin and Carbamazepine
• Any liver disease associated with coagulopathy
• Subjects who are pregnant, breastfeeding or potentially pregnant, or of childbearing age, sexually active and not practicing an effective method of birth prevention (e.g. prescription oral contraceptives, contraceptive injections, intrauterine device, double barrier method, patch contraceptive, sterilization of the male partner)

Sponsors & Collaborators

• Istituti Clinici Scientifici Maugeri SpA: lead
• Società Italiana Cardiologia Ospedalità Accreditata (SICOA): collaborator

Study Sites (1)

Istituti Clinici Scientifici Maugeri

Milan, Italy

RECRUITING

MeSH Terms

Interventions

Observation

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Central Study Contacts

Laura Adelaide Dalla Vecchia, MD

CONTACT

+390250725120; laura.dallavecchia@icsmaugeri.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 25, 2024
• First Posted: February 2, 2024
• Study Start: March 31, 2022
• Primary Completion: March 31, 2024
• Study Completion: March 31, 2024
• Last Updated: February 8, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)